drugset / Trial / NCT01821833

Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel

NCT01821833

RandomizedParallel-groupDouble-blindSupportive care

Summary

Paclitaxel, a widely used chemotherapeutic agent, is associated with several well-known side effects including neuropathy (weakness, numbness and pain) and generalized body aches. The latter has recently been described as paclitaxel-associated acute pain syndrome (P-APS) and often occurs in the first three to four days after administration. It affects about 58-90% of patients. Currently, the mechanism of P-APS is unknown, and there is no standard of care to treat it. However, an intervention with both anti-inflammatory as well as neuroprotective properties would be an ideal candidate for testing in the prevention of P-APS and subsequent development of peripheral neuropathy. Previous studies have suggested that omega-3 fatty acids may act as neuroprotective agents, and there are no currently documented safety concerns with their combined use with paclitaxel. Therefore, this randomized pilot clinical trial will determine whether omega-3 fatty acids can treat pain in patients with breast or ovarian cancer receiving paclitaxel.

Timeline

Start
2016-05-24
Primary completion
2018-01-16
Completion
2022-08-03

Drugs

EvaluationDrugModalityDoseRoute
Background Paclitaxel Small molecule 70 mg/m2 Intravenous
Background Paclitaxel Small molecule 90 mg/m2 Intravenous